Ammar Mousa
Regulatory Affairs Manager
Riyadh
Summary
Experienced Regulatory Affairs and Pharmacovigilance Manager with over 20 years in the pharmaceutical industry. Proven track record in managing product registration, licensing, and compliance with SFDA and GCC regulations. Skilled in leading scientific offices, government relations, and quality assurance. Strong background in pharmacovigilance systems, dossier preparation, and stakeholder engagement. Committed to ensuring drug safety and regulatory excellence across the healthcare sector.
Overview
22
22
years of professional experience
Work History
Quality, Regulatory affairs mgr. & deputy QPPV
AL-Safa warehouse company Ltd.
01.2024 - Current
- Managing new MAH registration & renewal at SFDA & GCC centrally.
- Maintaining current registered products regarding renewal of the marketing authorization holder and variation submission in addition to the management of responses versus comments that raised by HA’s (SFDA & GCC).
- Management of labelling activities corresponding to HA guidelines in addition to updating of labelling text according to company variations and safety matters.
- Registration and renewal of manufacturing sites, facilitating for health authorities inspection visits and proceeding for issuing certifications.
- Deputy PV:
- Ensuring the proper conduct of pharmacovigilance activities in the absence of QPPV.
- Contact point for pharmacovigilance inspections under QPPV supervision.
- ADRs collecting, reporting, and submitting to MAHs and SFDA under the supervision of QPPV.
- Submission of all pharmacovigilance documents per SFDA GVP guidelines.
- Ensuring the conduct of pharmacovigilance activities under the supervision of QPPV.
- To have an overview of the drug’s safety profiles.
- To have an awareness of any conditions and obligations related to the products or committed to the SFDA at any stage.
Freelancer
12.2019 - Current
- Pharmaceutical consultation in regards of preparation of dossiers, submission and pricing.
- Studying and Evaluation the product dossiers before submission.
- Implementation of the local guidelines and planning of MOL/GOSI and SFDA legislation in terms of localizing and Saudization of jobs.
Regulatory Affairs & Scientific Office manager
Shire export services GmbH
04.2016 - 10.2019
- Registration of new company products at Saudi FDA level & centrally at GCC level.
- Updating product MAH license/renewal for current registered products.
- Updating the current registered products through submission of variation in terms of quality changes, labelling & pricing.
- Registration new company manufacturing sites of and renewal the current registered ones at both levels SFDA & GCC.
- Arrangement of GMP inspection committees to SFDA & GCC health authorities.
- Arrangement & submission for bidding into local central for MOH and military hospitals tender.
- Contracting third parties in terms of suppliers, finance and pay roles, Governmental relations office, legal firms and advertising agencies.
- Scientific Office Manager:
- Maintain all TSO licenses and governmental accounts (SFDA, SAGIA, MOL and municipality).
- Work with medical Dep. to fulfil the requirements of government (SFDA) for PV System and process.
- Support of scientific activities process for all functions.
- Work with regulatory affairs dep. in new products Registration, renewal and updating PIL & packaging material.
- Work with Ethics and Compliance dep to fulfil the requirements of government and internal policies.
- Secure the Marketing Material and campaign approvals.
- Make sure that all legal employees licenses are valid and updated.
- Work with training dep in Saudi Pharmacy students training course.
- In partnership with Area GA teams, proactively develops and executes strategies and tactics to build strong and trusted relationships with government affairs stakeholders in order to shape a favorable environment for the company and guarantee freedom to operate.
- Develop a strategic plan that provides a continuous understanding of the healthcare environment, maps relevant stakeholders, understands their role in future healthcare policies and identifies key challenges and opportunities for the affiliate and specific brands.
- Develop effective relationships with local commercial organization, distributors and service providers in Saudi Arabia.
Regulatory affairs manager and Pharmacovigilance backup
Sanofi Pasteur
02.2012 - 01.2016
- Registration of new products: preparation of Module 1 regional administrative document, review and validation rest of registration dossier document provided by corporate from HQ. And thereafter managing the submission of dossiers.
- Maintaining current registered products regarding renewal of the marketing authorization holder and variation submission in addition to the management of responses versus comments that raised by HA’s (SFDA & GCC).
- Management of labelling activities corresponding to HA guidelines in addition to updating of labelling text according to company variations and safety matters.
- Registration and renewal of manufacturing sites, facilitating for health authorities inspection visits and proceeding for issuing certifications.
- Sales coordinator toward MOH, support sales force team particularly during Flu season campaigns. Follow up sales and consumption with MOH medical supply all over kingdom areas.
- Pharmacovigilance role, reporting adverse events and dispatching those reports to corporate in HQ.
- Support the PV department
- Scientific office manager Sanofi Pasteur from 2/1/2012 to 3/1/2016
- Roles:
- To ensure that the company is applying and sticks to the Saudi code of ethics in terms of practicing the marketing authorisation of pharmaceuticals.
- Updating the medical representatives’ licenses of Saudi commission for health specialties.
- Implementation of regulations and instructions issued by the authority.
- Support scientific activities in the relevant areas of the company products, participation in the activities of the scientific societies and contribute to the continuing education programs.
- Regulating for performing the clinical trials.
- Contribute to the studies and scientific research in collaboration with specialized scientific centers, according to the rules and ethics of scientific research.
- Provide appropriate trainings to the company's employees and pharmacy collages students regarding scientific office functions.
- Registering the company new products and maintaining marketing authorization licenses in terms renewals and submission the variations sequentially.
- Follow up the company’s pharmaceuticals after registration and marketing, and immediately inform the authority about any comments concerning the quality and effectiveness of the products or the emergence of new side effects after marketing.
- Support the health sector workers to attend scientific conferences.
- Follow-up the protection of patency affairs and the company rights of manufacturing pharmaceuticals products.
- Continue to update the internal leaflets and the outer packaging of registered pharmaceuticals and make sure to match their information to what is supported in the authority.
Sales supervisor
Manayer Najd co.
01.2010 - 01.2012
- Registration and renewal of distributor companies new products in SFDA and GCC, 4 lines of several products e.g Oncology & Blood products, Antibiotics and medicine, Herbals and food supplement.
- Managing and updating labelling text (leaflets & outer packs).
- Registration and renewal manufacturing sites, arrangement for health authorities inspection visits and then issuing certifications from local health authorities.
- Clearance of imported shipments and proceeding for local batch release.
- Facilitating for implementing local clinical trials throughout regulating with health authority and hospitals.
- Pricing for new registering products.
Regulatory affair coordinator
Manayer Najd co.
07.2008 - 01.2010
Sales Supervisor
Manayer Najd co.
05.2005 - 06.2007
Medical Representative
Manayer Najd co.
06.2003 - 12.2004
Education
Bachelor of pharmacy -
Al-Ahliyya Amman University
AmmanSkills
- Relevant experience with proven track record of success in government affairs or public policy
- Extensive, relevant contacts and network
- Ability to influence the development of legislation/policy and strong knowledge of the process
- Excellent knowledge of healthcare environment, key stakeholders, and public health and policy environment
- Strong networking skills, capable of developing and influencing relationships with internal colleagues and key external and political stakeholders
Interests
Camping & travelling, Watching movies, Walking & bike riding
Other Qualifications:
- Sales & marketing management course (01/01/2005-04/30/2005) unlimited skills training and consultancy in Jordan.
- Accounting theory & practice, marketing management as a part of MBA program Webster Graduate school London
- Pharmacovigilance
Timeline
Quality, Regulatory affairs mgr. & deputy QPPV
AL-Safa warehouse company Ltd.
01.2024 - Current
Freelancer
12.2019 - Current
Regulatory Affairs & Scientific Office manager
Shire export services GmbH
04.2016 - 10.2019
Regulatory affairs manager and Pharmacovigilance backup
Sanofi Pasteur
02.2012 - 01.2016
Sales supervisor
Manayer Najd co.
01.2010 - 01.2012
Regulatory affair coordinator
Manayer Najd co.
07.2008 - 01.2010
Sales Supervisor
Manayer Najd co.
05.2005 - 06.2007
Medical Representative
Manayer Najd co.
06.2003 - 12.2004
Bachelor of pharmacy -
Al-Ahliyya Amman University
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